PMA P180047S003
- Device
- LIAISON QuantiFERON TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S003
- Product code
- NCD
- Decision date
- 2020-07-23
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval of change in the LIAISON QuantiFERON-TB Gold Plus assay protocol reagent dispensation sequence.
Current openFDA PMA Record#
- Device
- LIAISON QuantiFERON TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S003
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2020-07-23
- Decision code
- APPR
- Date received
- 2020-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of change in the LIAISON QuantiFERON-TB Gold Plus assay protocol reagent dispensation sequence.